Technescan PYP 11.9 mg/10mL
Technetium Tc 99m Pyrophosphate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Curium US LLC
Technescan PYP is a injection, powder, lyophilized, for solution containing technetium tc 99m pyrophosphate at 11.9 mg/10mL, taken intravenous. Manufactured by Curium US LLC.
Key Facts
- Brand Name
- Technescan PYP
- Generic Name
- Technetium Tc 99m Pyrophosphate
- NDC Code (Product)
69945-094- Manufacturer
- Curium US LLC
- Strength
- 11.9 mg/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA017538
- Marketing Start
- 10/14/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Technescan PYP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for: • Skeletal imaging to demonstrate areas of altered osteogenesis in adults • Cardiac imaging as an adjunct in the diagnosis of acute myocardial infarction in adults (See WARNINGS ) Technescan PYP, in conjunction with sodium pertechnetate Tc 99m injection for red blood cell (RBC) labeling, is indicated for gated cardiac blood pool imaging and for the detection of gastrointestinal bleeding sites in adults.
Dosage & Administration
DOSAGE AND ADMINISTRATION Radiation Safety – Drug Handling After radiolabeling of Technescan PYP, the reaction vial contains Technetium Tc 99m Pyrophosphate Injection. Handle Technetium Tc 99m Pyrophosphate Injection with appropriate safety measures to minimize radiation exposure. (See PRECAUTIONS, General .) Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Pyrophosphate Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Recommended Dosage, Administration, and Imaging Instructions for Skeletal and Cardiac Imaging Dosing and Administration Instructions The recommended activity of Technetium Tc 99m Pyrophosphate Injection for each type of imaging is presented in Table 4. Administer Technetium Tc 99m Pyrophosphate Injection intravenously over 10 seconds to 20 seconds. Measure the patient dose with a dose calibrator im…
Warnings
WARNINGS Image interpretation errors can occur. As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the estimate of false negative image interpretations was 6%. False negative image interpretations can occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. In a study involving 22 patients in whom ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the estimates of false negative and false positive image interpretations were 23% and 9%, respectively. False positive image interpretations have been reported following coronary artery bypass graft surgery and in unstable angina pectoris, old myocardial infarcts, and cardiac contusions. Technetium Tc 99m pyrophosphate may impair brain imaging with sodium pertechnetate Tc 99m and result in false positive or false negative image interpretation. It is recommended, where feasible, that brain imaging precede skeletal imaging procedures. Gated cardiac blood pool and gastrointestinal bleed imaging may be impaired in patients receiving sodium heparin for anticoagulant the…
Contraindications
CONTRAINDICATIONS None known.
Drug Interactions
Drug Interactions The biodistribution of technetium Tc 99m pyrophosphate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m pyrophosphate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .)
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions associated with the use of Technescan PYP have been reported: flushing, hypotension, fever, chills, nausea, vomiting, and dizziness, as well as hypersensitivity reactions such as itching and various skin rashes.
Frequently Asked Questions
What is Technescan PYP used for?
Technescan PYP contains Technetium Tc 99m Pyrophosphate. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Technescan PYP a controlled substance?
Technescan PYP is not classified as a controlled substance by the DEA.
What is the generic name for Technescan PYP?
The generic name for Technescan PYP is Technetium Tc 99m Pyrophosphate. There are no other listed brand versions of Technetium Tc 99m Pyrophosphate.
What is the NDC code for Technescan PYP 11.9 mg/10mL?
The NDC (National Drug Code) for Technescan PYP 11.9 mg/10mL is 69945-094, listed by Curium US LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)